Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
686
Countries
11
Sites
73
Cancer-associated Cachexia
To investigate the efficacy of visugromab treatment, at various doses, in participants with cancer-associated cachexia
Key facts
- Sponsor
- CatalYm GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 26 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- CatalYm GmbH
External identifiers
- EU CT number
- 2025-523533-25-00
- WHO UTN
- U1111-1326-9842
- ClinicalTrials.gov
- NCT07112196
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Safety, Dose response, Others, Pharmacokinetic
To investigate the efficacy of visugromab treatment, at various doses, in participants with cancer-associated cachexia
Secondary objectives 4
- 1. To investigate additional efficacy parameters in participants with cancer-associated cachexia treated with visugromab
- 2. To investigate the safety and tolerability of visugromab in participants with cancer-associated cachexia
- 3. To evaluate changes in health-related quality-of-life (HRQoL) assessments from baseline in participants with cancer-associated cachexia treated with visugromab
- 4. To investigate pharmacokinetics (PK) of visugromab in peripheral blood in participants with cancer-associated cachexia treated with visugromab
Conditions and MedDRA coding
Cancer-associated Cachexia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10064015 | Cancer cachexia | 10027433 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Male and female participants aged ≥ 18 years at screening
- 2. Weight loss
- 3. Advanced cancer
- 4. Other protocol-defined criteria apply
Exclusion criteria 2
- 1. Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product
- 2. Other protocol-defined criteria apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in body weight at 12 weeks; change from baseline in appetite at 12 weeks, measured on the 5-item anorexia subscale of the FAACT instrument, 12 weeks
Secondary endpoints 4
- 1. Skeletal muscle mass/index by L3 CT/MRI scan; Functional endpoint (30-second chair stand test); Non-sedentary physical activity; Overall survival (OS); Tumor response; Responder analysis
- 2. Incidence, type, and severity of treatment emergent Adverse Events (TEAEs), treatment-related AEs and serious AEs (SAEs), discontinuation due to TEAEs
- 3. Patient-reported outcomes: Functional Assessment of Anorexia/Cachexia Therapy (FAACT); Patient Global Impression of Severity (PGI-S); Patient Global Impression of Change (PGI-C); EORTC-QLQ-C15 PAL
- 4. Maximum plasma concentration (Cmax); Minimum plasma concentration (Cmin)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8524649 · Product
- Active substance
- Visugromab
- Substance synonyms
- Anti-GDF-15 humanised hinge-stabilized IgG4 monoclonal antibody, CTL-002
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- CATALYM GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo matching Visugromab (CTL-002)
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CatalYm GmbH
- Sponsor organisation
- CatalYm GmbH
- Address
- Am Klopferspitz 19, Martinsried Martinsried
- City
- Planegg
- Postcode
- 82152
- Country
- Germany
Scientific contact point
- Organisation
- CatalYm GmbH
- Contact name
- Regulatory Department
Public contact point
- Organisation
- CatalYm GmbH
- Contact name
- Regulatory Department
Third parties 17
| Organisation | City, country | Duties |
|---|---|---|
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Median Technologies ORG-100041462
|
Valbonne, France | Other |
| Biomapas UAB ORG-100009725
|
Kaunas, Lithuania | Code 12 |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Code 8 |
| Mlm Medical Labs GmbH ORG-100043721
|
Moenchengladbach, Germany | Laboratory analysis |
| Alderley Analytical Limited ORG-100047986
|
Macclesfield, United Kingdom | Laboratory analysis |
| FACIT.Org Inc. ORG-100048771
|
Ponte Vedra, United States | Other |
| Metronomia Clinical Research GmbH ORG-100012892
|
Munich, Germany | Data management |
| European Organisation For Research And Treatment Of Cancer ORG-100010848
|
Sint-Lambrechts-Woluwe, Belgium | Other |
| Discovery Life Sciences LLC ORG-100046461
|
Huntsville, United States | Laboratory analysis |
| Metabolon Inc. ORG-100049955
|
Morrisville, United States | Laboratory analysis |
| Eurofins Adme Bioanalyses ORG-100034510
|
Vergeze, France | Laboratory analysis |
| Amicus Clinical Development Limited ORG-100053120
|
Cambridge, United Kingdom | Code 5 |
| August Research OOD ORG-100040588
|
Sofia, Bulgaria | Code 12 |
| Medpace Finland Oy ORG-100009147
|
Helsinki, Finland | On site monitoring, Code 12, Code 13, Code 2, Code 5 |
| Actigraph LLC ORG-100043702
|
Pensacola, United States | Other |
| Fisher Bioservices Inc. ORG-100011655
|
Rockville, United States | Code 14 |
Locations
11 EU/EEA countries · 73 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 23 | 4 |
| Czechia | Authorised, recruiting | 24 | 6 |
| France | Authorised, recruiting | 44 | 6 |
| Germany | Authorised, recruiting | 44 | 10 |
| Ireland | Authorised, recruitment pending | 30 | 2 |
| Italy | Ongoing, recruiting | 44 | 8 |
| Netherlands | Authorised, recruitment pending | 30 | 2 |
| Norway | Authorised, recruiting | 25 | 5 |
| Poland | Ongoing, recruiting | 80 | 13 |
| Romania | Ongoing, recruiting | 42 | 8 |
| Spain | Authorised, recruiting | 48 | 9 |
| Rest of world
Serbia, Australia, Canada, Turkey, Korea, Republic of, Georgia, Switzerland, United States, United Kingdom, Taiwan
|
— | 252 | — |
Investigational sites
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD
Department of medical oncology, Bulevard Siedinenie 49, 6304, Haskovo
Complex Oncology Center Vratsa EOOD
Medical oncology department, Bulevard Vtori Yuni 68, 3000, Vratsa
Mbal Za Zhensko Zdrave Nadezhda OOD
Clinic of medical oncology, Blaga Vest Street 3, 1330, Sofia
Medical Centre Futuremeds EOOD
-, 1st Floor, Ulitsa Filip Makedonski 37, Plovdiv
Multiscan s.r.o.
Onkologie Nemocnice Hořovice, K Nemocnici 1106, 268 31, Horovice
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
University Hospital Olomouc
Onkologická klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice V Motole
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague
Vseobecna Fakultni Nemocnice V Praze
Onkologická klinika, Fakultní poliklinika, Karlovo Namesti 554/32, Nove Mesto, Prague 2
Fakultni Nemocnice Brno
Klinika nemocí plicních a tuberkulózy, Jihlavska 340/20, Bohunice, Brno
Assistance Publique Hopitaux De Paris
oncologie, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
Medical oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Regional Lutte Contre Le Cancer
Medical oncology, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Centre Hospitalier Regional Et Universitaire De Brest
oncology, Boulevard Tanguy Prigent, 29200, Brest
Assistance Publique Hopitaux De Paris
Medical oncology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Medical Center - University Of Freiburg
Dept. of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Wuerzburg AöR
Interdisciplinary Study Center with Early Clinical Trial Unit, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Johanniter GmbH
Internal Medicine Hematooncology, Johanniterstrasse 3-5, Zentrum, Bonn
Technische Universitaet Dresden
Oncology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Muenchen Klinik gGmbH
Hematology and Oncology, Oskar-Maria-Graf-Ring 51, Ramersdorf-Perlach, Munich
LungenClinic Grosshansdorf GmbH
LungenClinic Großhansdorf GmbH, Woehrendamm 80, 22927, Grosshansdorf
Universitaetsklinikum Erlangen AöR
Dep.of Medicine 1-Gastroentero.,Pneumo.,and Endocrino.,Hector-Center for Nutrition,Exercise, Sports, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Koeln AöR
Department I of Internal Medicine, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Center of Tumor Diseases, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsmedizin Greifswald KöR
Klinik und Poliklinik für Innere Medizin A, -, 17475, Greifswald
St James's Hospital
School of Medicine, James's Street, D08 NHY1, Dublin 8
St Vincent's University Hospital
School of Medicine, Elm Park Merrion Road, D04 T6F4, Dublin 4
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
S.C.Oncologia Medica, Piazzale Spedali Civili 1, 25123, Brescia
Humanitas Mirasole S.p.A.
UO Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Centro Ricerche Cliniche Di Verona S.r.l.
Oncologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Universita' Degli Studi Di Ferrara
UO Oncologia, Via Aldo Moro 8, 44124, Ferrara
Fondazione IRCCS Policlinico San Matteo
Oncologia, Viale Camillo Golgi 19, 27100, Pavia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Unita Sanitaria Locale Di Piacenza
Oncoematologia, Via Giuseppe Taverna 49, 29121, Piacenza
Centro Di Riferimento Oncologico Di Aviano
Oncologia Medica, Via Franco Gallini 2, 33081, Aviano
Academisch Ziekenhuis Maastricht
Medical Oncology, P Debyelaan 25, 6229 HX, Maastricht
Dijklander Ziekenhuis
Internal Medicine, Maelsonstraat 3, 1624 NP, Hoorn Nh
Oslo University Hospital HF
Department of Oncology, Taarnbygget, Kirkeveien 166, Oslo
St. Olavs Hospital HF
Cancer Clinic, Prinsesse Kristinas Gate 3, 7030, Trondheim
Akershus University Hospital
Akershus University Hospital, Sykehusveien 25, 1474, Loerenskog
Helse Bergen HF
Cancer Clinic, Jonas Lies Vei 65, 5021, Bergen
Sorlandet Sykehus HF
Sørlandet Hospital, Kristiansand, Egsveien 100, 4615, Kristiansand S
Jagiellonskie Centrum Innowacji Sp. z o.o.
Poradnia Onkologiczna, Ul. Profesora Michala Bobrzynskiego 14, 30-348, Cracow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Chorób Rozrostowych, Ul. Pabianicka 62, 93-513, Lodz
Pratia Hematologia Sp. z o.o.
Poradnia Onkologiczna, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Oddział Onkologii Klinicznej z Pododdziałem Dziennym, Os. Zlotej Jesieni 1, 31-826, Cracow
Futuremeds Sp. z o.o.
FutureMeds Warszawa Targówek, Ul. Sw. Wincentego 93/7, 03-291, Warsaw
Regionalny Szpital Specjalistyczny Im. Dr. Wladyslawa Bieganskiego
Poradnia Onkologiczna, Ul. Dr. Ludwika Rydygiera 15/17, 86-300, Grudziadz
Pratia S.A.
Pratia MCM Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
Futuremeds Sp. z o.o.
FutureMeds Łódź, Ul. Gruszowa 2, 91-363, Lodz
Futuremeds Sp. z o.o.
FutureMeds Kraków, Ul. Mikolaja Kopernika 32, 31-501, Cracow
Futuremeds Sp. z o.o.
FutureMeds Wrocław, Ul. Legnicka 16, 53-673, Wroclaw
Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska sp.j.
MS Pneumed, Polnocna 18 Lok U1, 20-064, Lublin
Pratia S.A.
Pratia Onkologia Wrocław, Ul. Marsz. Jozefa Pilsudskiego 69, 50-019, Wroclaw
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Oddział Onkologii Klinicznej Chemioterapii, Ul. Michala Kleofasa Oginskiego 6, 58-506, Jelenia Gora
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Gral Medical S.R.L.
Oncologie Medicala, Spitalul Oncofort, Aleea Doctor Ana Aslan Nr 15, Pitesti
Ovidius Clinical Hospital S.R.L.
Oncologie, Hematologie, Dn 2a Km 202 880, 905900, Ovidiu
Oncolab S.R.L.
Oncologie, Strada Bujorului 7, 200385, Craiova
Pelican Impex S.R.L.
Oncologie Medicala, Calea Coposu Corneliu 14a-14b, 410469, Oradea
Oncomed S.R.L.
Oncologie Medicala, Porumbescu Ciprian 57-59, 300239, Timisoara
Futuremeds S.R.L.
Oncologie Medicala, Calea Bucuresti Nr. 318, 500299, Brasov
Futuremeds S.R.L.
Oncologie, Aleea Meteo 4, 800183, Galati
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
Area Sanitaria Da Coruna E Cee
Medical Oncology, Lugar Jubias De Arriba Num 84, 15006, A Coruna
Futuremeds Spain S.L.
Oncology, Calle De La Granja 8, 28003, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
Oncology, Pio XII Etorbidea 36, 31008, Pamplona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2026-03-26 | 2026-04-02 | |||
| Czechia | 2026-07-06 | ||||
| France | 2026-03-26 | ||||
| Germany | 2026-05-08 | ||||
| Italy | 2026-04-14 | 2026-06-11 | |||
| Norway | 2026-04-14 | ||||
| Poland | 2026-04-28 | 2026-05-20 | |||
| Romania | 2026-04-15 | 2026-06-24 | |||
| Spain | 2026-03-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 158 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Protocol (for publication) | D4_Patient facing documents_BG_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_BG_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_BG_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_BG_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_CS_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_CS_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_CS_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_CS_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_DE_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_DE_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_DE_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_DE_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_EN_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_EN_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_EN_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_ES_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_ES_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_ES_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_FR_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_FR_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_FR_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_IT_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_IT_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_IT_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_NO_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_NO_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_NO_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_NO_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_PL_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_PL_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_PL_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_RO_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_RO_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_RO_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_RO_PGI-S_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_UK_EORTC-QLQ-C15-PAL_CatalYm | 1 |
| Protocol (for publication) | D4_Patient facing documents_UK_FAACT_CatalYm | 4 |
| Protocol (for publication) | D4_Patient facing documents_UK_PGI-C_CatalYm | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_UK_PGI-S_CatalYm | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements and Informed consent procedure_2025-523533-25_CatalYm | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_CatalYm | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_CatalYm_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ_Catalym | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE_Catalym | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_ES_CatalYm | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_CatalYm GmbH | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT_ CatalYm GmbH | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL_CatalYm | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO_CatalYm | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL_ CatalYm GmbH | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_RO_CatalYm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements_Patient Brochure_CZ_Catalym | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Ametris Participant Guide_BG_CatalYm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_ CatalYm GmbH | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BG_CatalYm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_CatalYm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_CatalYm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Catalym | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_CatalYm GmbH | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_IT_CatalYm GmbH | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_RO_CatalYm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_ CatalYm GmbH | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_BG_CatalYm | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_BG_CatalYm_TC | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_Catalym | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_CatalYm GmbH | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_IT_CatalYm GmbH | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Handbook_RO_CatalYm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Brochure_2025-523533-25_CatalYm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Handbook_CatalYm | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Handbook_CatalYm | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Participant Flyer_ 2025-523533-25_CatalYm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Pre-screening Checklist_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy ICF_ CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GDPR_Catalym | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult Part 1 _ CatalYm GmbH_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult Part 2 _ CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_CatalYm_BG_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_CatalYm_EN_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_CatalYm_ENG_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_CatalYm_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_Catalym_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 1_CatalYm_RO_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_CatalYm_BG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_CatalYm_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_CatalYm_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_CatalYm_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_Catalym_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF Part 2_CatalYm_RO | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1 ICF_Catalym_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main part 1_ CatalYm GmbH _redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1_CatalYm GmbH_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1_CatalYm_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1_CatalYm_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2 ICF_Catalym | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_ CatalYm GmbH | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_CatalYm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_CatalYm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PCS_Personal Data Travel Addendum_Catalym | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF_Catalym | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF_Catalym_BG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP ICF_CatalYm_EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_ CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_CatalYm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy ICF_CatalYm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_CatalYm | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_CatalYm_ENG | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_CatalYm_RO | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner or Participant_CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner or Participant_CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Catalym_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Catalym_TC | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Main Part 1_2025-523533-25_CatalYm_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Main Part 2_2025-523533-25_CatalYm_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Pregnancy ICF_2025-523533-25_CatalYm_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ GPLetter_2025-523533-25_CatalYm_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Participant PCS Clinical Consent_ CatalYm GmbH | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ametris Participant Guide_ CatalYm GmbH | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EmergencyCard_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_ CatalYm GmbH | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_Catalym | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HCPFlyer_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Guide_CatalYm GmbH | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ParticipantHandbook_2025-523533-25_CatalYm | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientEmergencyCard_ CatalYm GmbH | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PatientEmergencyContactCard_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS Travel and Reimbursement Policy_CatalYm | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_PatientContactCard_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_PatientDebitCard_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_PaymentAccountFAQ_2025-523533-25_CatalYm | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_PayQuickerAccountRegistrationGuide_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_PCS_PatientFolder_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_PCS_PatientWelcomeLetter_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PCS_Personal Data Travel Addendum_2025-523533-25_CatalYm | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PreScreeningChecklist_CatalYm | 1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_BG_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_CS_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_EN_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_ES_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_FR_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_IT_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay protocol synopsis_NL_2025-523533-25 _CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_NO_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_PL_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis_RO_2025-523533-25_ CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CS_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2025-523533-25_CatalYm_redacted | 2.4_EU |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2025-523533-25_CatalYm_redacted | 2.4_EU |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-10 | France | Acceptable 2026-02-13
|
2026-02-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-26 | Acceptable | 2026-05-13 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-26 | Acceptable | 2026-03-17 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-27 | France | Acceptable | 2026-04-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-27 | Acceptable | 2026-05-06 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-27 | Acceptable | 2026-03-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-02 | Acceptable | 2026-06-05 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-03-02 | Acceptable | 2026-04-28 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2026-03-02 | Acceptable | 2026-04-20 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-03-03 | Acceptable | 2026-05-04 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2026-03-04 | Acceptable 2026-02-13
|
2026-05-29 | |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2026-03-05 | 2026-06-01 | ||
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-06-05 | France | 2026-06-05 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-06-10 | Acceptable | 2026-07-01 |